Crumlin (North), N/A, Ireland
Randox Laboratories Ltd. recalls
61 recalls recorded since 2018, most recently on 20 December 2024. 23 are listed as ongoing. Status and classification are as published by the FDA.
Recalls61
Ongoing (FDA)23
Terminated or completed38
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 December 2024
- Reason
- Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- Distribution
- US Nationwide distribution Including PR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1018-2025, Z-1017-2025
- Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
- Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Ongoing Class II Medical devices
- Recall started
- 7 June 2024
- Reason
- Cystatin C Reagent marketed without a 510 (k)
- Distribution
- US Nationwide distribution in the states of AL, CA, GA, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2425-2024
- RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Ongoing Class III Medical devices
- Recall started
- 5 April 2024
- Reason
- Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1786-2024
- Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
Ongoing Class II Medical devices
- Recall started
- 5 March 2024
- Reason
- Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
- Distribution
- Domestic: Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1759-2024
- Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Ongoing Class II Medical devices
- Recall started
- 1 March 2024
- Reason
- The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
- Distribution
- Domestic: CA, FL, IL, ME, NJ, OH, & OR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1328-2024
- Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Ongoing Class II Medical devices
- Recall started
- 14 February 2024
- Reason
- Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
- Distribution
- US Nationwide distribution in the states of CA, IN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1369-2024
- Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Ongoing Class II Medical devices
- Recall started
- 31 January 2024
- Reason
- Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
- Distribution
- US Nationwide distribution in the states of GA, MA, WV including PR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1593-2024, Z-1594-2024
- Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
- Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Ongoing Class II Medical devices
- Recall started
- 29 November 2023
- Reason
- Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.
- Distribution
- US Nationwide distribution in the states of SC and OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0992-2024
- RX Series Copper (Cu) Assay Ref. Number CU2340
Ongoing Class II Medical devices
- Recall started
- 20 November 2023
- Reason
- Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
- Distribution
- US Nationwide including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0753-2024
- Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Ongoing Class II Medical devices
- Recall started
- 20 November 2023
- Reason
- CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
- Distribution
- US Nationwide and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0752-2024
- Calibration Serum Level 3 CAL2351
Ongoing Class II Medical devices
- Recall started
- 13 November 2023
- Reason
- There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0751-2024
- Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
Ongoing Class III Medical devices
- Recall started
- 6 November 2023
- Reason
- A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
- Distribution
- NY, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0624-2024
- SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM anti
Ongoing Class II Medical devices
- Recall started
- 11 October 2023
- Reason
- Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
- Distribution
- US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0501-2024
Ongoing Class II Medical devices
- Recall started
- 6 September 2023
- Reason
- RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
- Distribution
- US Nationwide distribution including Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0201-2024, Z-0202-2024, Z-0200-2024, Z-0198-2024, Z-0199-2024
- RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
- RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
- RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
- RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
- RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Ongoing Class II Medical devices
- Recall started
- 3 August 2023
- Reason
- there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
- Distribution
- US States: GA, OH, OR, PA, TX, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2609-2023
- Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Ongoing Class II Medical devices
- Recall started
- 19 July 2023
- Reason
- As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.
- Distribution
- CA, FL, IL, ME, MI, NC, OH, PA,NJ,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2448-2023
- Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue N
Ongoing Class II Medical devices
- Recall started
- 21 June 2023
- Reason
- (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2446-2023
- Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phos
Ongoing Class II Medical devices
- Recall started
- 13 June 2023
- Reason
- Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
- Distribution
- US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2362-2023
- Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Ongoing Class III Medical devices
- Recall started
- 4 May 2023
- Reason
- Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
- Distribution
- CA, IL, VA, WA, WI including PR
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2021-2023, Z-2022-2023
- Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
- Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
Ongoing Class II Medical devices
- Recall started
- 1 February 2023
- Reason
- The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
- Distribution
- PA, OH, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1286-2023
- CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Ongoing Class II Medical devices
- Recall started
- 22 November 2022
- Reason
- Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- Distribution
- US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0904-2023, Z-0903-2023, Z-0905-2023
- Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
- Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
- Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
Terminated Class II Medical devices
- Recall started
- 1 November 2022
- Terminated
- 18 June 2024
- Reason
- Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results
- Distribution
- US Nationwide Distribution: CA, NC, NJ and WV,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0363-2023, Z-0362-2023
- IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
- IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
Terminated Class II Medical devices
- Recall started
- 1 August 2022
- Terminated
- 13 December 2024
- Reason
- ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg
- Distribution
- US Nationwide distribution in the states of WV, NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1772-2022
- The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid
Terminated Class II Medical devices
- Recall started
- 22 June 2022
- Terminated
- 10 May 2024
- Reason
- Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
- Distribution
- Nationwide Distribution - MD, OR, PR, MT, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1424-2022
- Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Terminated Class III Medical devices
- Recall started
- 9 June 2022
- Terminated
- 8 February 2024
- Reason
- A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.
- Distribution
- US Nationwide distribution in the state of IL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1422-2022, Z-1423-2022
- Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
- Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Terminated Class III Medical devices
- Recall started
- 25 March 2022
- Terminated
- 26 December 2023
- Reason
- Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.
- Distribution
- Domestic distribution to WV and PR. International distribution to Bangladesh, Bosnia & Herzegovina, Botswana, China, Colombia, Costa Rica, Croatia, Egypt, Fiji, France, Georgia, Germany, Ghana, Greece, Grenada, Hong Kong, India, Iraq, Italy, Lithuania, Malaysia, Maldives, Malta, Mexico, Morocco, Moz
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1097-2022
- CK MB Calibrator, Catalogue Number CK2393
Terminated Class II Medical devices
- Recall started
- 1 November 2021
- Terminated
- 9 March 2023
- Reason
- When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
- Distribution
- US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0328-2022
- RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Terminated Class II Medical devices
- Recall started
- 10 May 2021
- Terminated
- 10 November 2021
- Reason
- Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples
- Distribution
- US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2099-2021
- NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Terminated Class II Medical devices
- Recall started
- 28 April 2021
- Terminated
- 3 December 2021
- Reason
- An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
- Distribution
- US Nationwide Distribution and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2013-2021
- Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Terminated Class II Medical devices
- Recall started
- 29 March 2021
- Terminated
- 22 November 2021
- Reason
- Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.
- Distribution
- Domestic: IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, MS. Foreign: Albania, Argentina, Australia, Bangladesh, Bolivia, Bosnia & Herzegovina, Cameroon, Canada, Colombia, Cyprus, Denmark, Egypt, Estonia, Fiji, France, Germany, Greece, Hong Kong, Iraq, Italy, Ireland, Jordan, Kazakhstan, Ke
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1563-2021
- Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Terminated Class II Medical devices
- Recall started
- 13 November 2020
- Terminated
- 1 April 2021
- Reason
- Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
- Distribution
- US Nationwide distribution in the states of GA, NJ.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0546-2021, Z-0547-2021
- Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
- Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
Terminated Class II Medical devices
- Recall started
- 11 August 2020
- Terminated
- 15 October 2020
- Reason
- An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.
- Distribution
- US Nationwide distribution including in the states of WV, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2963-2020, Z-2962-2020
- Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for
- Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suita
Terminated Class II Medical devices
- Recall started
- 30 July 2020
- Terminated
- 3 February 2021
- Reason
- Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
- Distribution
- US Distribution to states of: VA, UT, WV and country of : Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2965-2020, Z-2966-2020
- AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
- AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Terminated Class II Medical devices
- Recall started
- 10 July 2020
- Terminated
- 17 June 2021
- Reason
- Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.
- Distribution
- New Mexico, Massachusetts, WV. Foreign distribution to Bolivia BOSNIA AND HERZEGOVINA Brazil Colombia Costa Rica Cyprus Egypt France Greece Grenada India Iraq Italy Jordan Kazakhstan Kenya Lithuania Mauritius Nepal Nigeria Pakistan Peru Philippines Poland Portugal Qa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2923-2020, Z-2924-2020
- Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
- Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Terminated Class II Medical devices
- Recall started
- 26 June 2020
- Terminated
- 19 October 2020
- Reason
- Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2753-2020, Z-2752-2020, Z-2751-2020
- Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
- Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
- Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Ongoing Class II Medical devices
- Recall started
- 18 February 2020
- Reason
- The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1547-2020
- Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accura
Terminated Class II Medical devices
- Recall started
- 19 December 2019
- Terminated
- 23 April 2021
- Reason
- Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample identification number) when searching the run/results screen; 2) Incorrect color flagging of IQC as "out of range."
- Distribution
- US Nationwide distribution including state of PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1349-2020
- RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For u
Terminated Class III Medical devices
- Recall started
- 13 December 2019
- Terminated
- 2 October 2020
- Reason
- A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).
- Distribution
- US: NY and DE OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1100-2020
- Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Terminated Class II Medical devices
- Recall started
- 4 October 2019
- Terminated
- 6 July 2020
- Reason
- Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
- Distribution
- US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0414-2020, Z-0412-2020, Z-0413-2020
- Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
- Randox Liquid Cardiac Controls Catalogue Number CQ5051
- Randox Liquid Cardiac Controls Catalogue Number CQ5052.
Terminated Class III Medical devices
- Recall started
- 23 September 2019
- Terminated
- 7 May 2020
- Reason
- Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
- Distribution
- WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0367-2020
- RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Terminated Class II Medical devices
- Recall started
- 9 August 2019
- Terminated
- 8 January 2021
- Reason
- The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.
- Distribution
- US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0283-2020, Z-0282-2020
- Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Comp
- Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quan
Terminated Class III Medical devices
- Recall started
- 25 July 2019
- Terminated
- 3 December 2020
- Reason
- Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
- Distribution
- US Nationwide distribution including the states of IN, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2557-2019
- Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Terminated Class III Medical devices
- Recall started
- 12 July 2019
- Terminated
- 17 June 2020
- Reason
- Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
- Distribution
- Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2490-2019
- This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and ac
Terminated Class II Medical devices
- Recall started
- 24 June 2019
- Terminated
- 21 May 2020
- Reason
- There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
- Distribution
- Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2083-2019, Z-2084-2019
- RX Daytona, Model Nos. RX4040 and RX4041
- RX Imola, Model Nos. RX4900
Terminated Class II Medical devices
- Recall started
- 11 June 2019
- Terminated
- 15 May 2020
- Reason
- The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
- Distribution
- US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2150-2019
- Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of
Terminated Class III Medical devices
- Recall started
- 10 June 2019
- Terminated
- 16 June 2020
- Reason
- The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
- Distribution
- Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2207-2019
- Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Terminated Class II Medical devices
- Recall started
- 3 April 2019
- Terminated
- 9 October 2019
- Reason
- The target values and ranges in these lots are incorrect.
- Distribution
- The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1255-2019, Z-1254-2019
- G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
- G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
Terminated Class II Medical devices
- Recall started
- 11 March 2019
- Terminated
- 15 May 2020
- Reason
- Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.
- Distribution
- Product distributed to CA, DE, WV, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1785-2019
- Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Terminated Class II Medical devices
- Recall started
- 13 February 2019
- Terminated
- 14 April 2020
- Reason
- An error in the assignment of the control range pH in Blood Gas Control
- Distribution
- US Distribution to state of: WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1057-2019
- Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target val
Terminated Class III Medical devices
- Recall started
- 7 February 2019
- Terminated
- 8 June 2020
- Reason
- The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
- Distribution
- The products were distributed to the following US states: WV and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1107-2019, Z-1105-2019, Z-1106-2019
- Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analyt
- Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of an
- Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility
Terminated Class II Medical devices
- Recall started
- 4 December 2018
- Terminated
- 18 June 2020
- Reason
- Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
- Distribution
- WV, PR
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0839-2019, Z-0840-2019
- Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
- Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
Ongoing Class II Medical devices
- Recall started
- 3 December 2018
- Reason
- The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.
- Distribution
- US Distribution to states to: CA, ME. MI, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1018-2019, Z-1016-2019, Z-1017-2019
- Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
- Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
- Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Terminated Class II Medical devices
- Recall started
- 19 November 2018
- Terminated
- 23 April 2020
- Reason
- Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
- Distribution
- US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0660-2019
- SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Terminated Class II Medical devices
- Recall started
- 2 October 2018
- Terminated
- 30 May 2019
- Reason
- Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
- Distribution
- Distributed to IN, NY, PR, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0382-2019, Z-0381-2019, Z-0380-2019
- Liquid Cardiac Control, CQ5053
- Liquid Cardiac Control, CQ5052
- Liquid Cardiac Control, CQ5051
Terminated Class II Medical devices
- Recall started
- 8 June 2018
- Terminated
- 5 November 2018
- Reason
- The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
- Distribution
- Worldwide Distribution - US in the state of WV. Foreign distribution to Australia, Chile, China, Germany, Hungary, Ireland, Italy, Moldova, Netherlands, Peru, Poland, Saudi Arabia, Slovakia, Spain, Sultanate of Oman, UAE, UK, and Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2575-2018
- Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
Terminated Class II Medical devices
- Recall started
- 22 May 2018
- Terminated
- 17 November 2020
- Reason
- The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.
- Distribution
- Distributed to accounts in CA, IN, KS, ME, and WV, and PR. Foreign distribution to Australia, Bangladesh, Belarus, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Cyprus, Denmark, Dutch Caribbean, Ecuador, Egypt, El Salvador, Ethiopia, Falkland Islands, Finland, France, Georgia, Germany,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2279-2018, Z-2278-2018, Z-2280-2018
- Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
- Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
- Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
Terminated Class II Medical devices
- Recall started
- 4 May 2018
- Terminated
- 16 June 2020
- Reason
- Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
- Distribution
- US Distribution including Puerto Rico and the state of : West Virginia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2059-2018
- RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Terminated Class II Medical devices
- Recall started
- 2 March 2018
- Terminated
- 11 April 2019
- Reason
- Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
- Distribution
- US Nationwide Distribution in the states of West Virginia and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1631-2018
- Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasm
Terminated Class III Medical devices
- Recall started
- 11 August 2017
- Terminated
- 29 March 2019
- Reason
- The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
- Distribution
- Distribution US nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0969-2018, Z-0970-2018
- Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
- Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Terminated Class II Medical devices
- Recall started
- 8 August 2017
- Terminated
- 5 September 2018
- Reason
- Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0937-2018
- Liquid Cardiac Control CQ5053
Terminated Class II Medical devices
- Recall started
- 7 June 2017
- Terminated
- 2 July 2018
- Reason
- Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product.
- Distribution
- Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0285-2018
- Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packagi
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.